S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy

Phase 2

Completed

• Conditions: Bladder Cancer; Transitional Cell Cancer of the Renal Pelvis and Ureter; Urethral Cancer
• Interventions: Drug: irinotecan hydrochloride

• Registration Number: NCT00066612
• Lead Sponsor: SWOG Cancer Research Network

Brief Summary

RATIONALE: Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent or refractory advanced transitional cell cancer of the urothelium.

Detailed Description

OBJECTIVES:

* Determine the probability of response (confirmed complete and partial response) to treatment with irinotecan in patients with recurrent or refractory advanced transitional cell carcinoma of the urothelium previously treated with platinum-based chemotherapy.

* Determine the qualitative and quantitative toxic effects of this drug in these patients.

* Determine the overall and progression-free survival of patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).

Patients receive irinotecan IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10 months.

Study Timeline

• Study Start: 2003-07
• Study First Submitted: 2003-08-06
• Study First Submitted QC: 2003-08-06
• Study First Posted: 2003-08-07
• Primary Completion: 2007-08
• Study Completion: 2010-05
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-31
• Last Update Posted: 2012-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	irinotecan hydrochloride	Irinotecan

Primary Outcome Measures

Name	Time	Method
Probability of response (confirmed complete and partial response)	From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years

Secondary Outcome Measures

Name	Time	Method
Number and grade of adverse events	From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
Overall survival	From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years
Progression-free survival	From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years